Washington: A major new study proves that the antiviral drug remdesivir is effective in saving people with serious cases of COVID-19, top US doctor Anthony Fauci said on Wednesday. Fauci, speaking at the White House, said “the data shows remdesivir has a clear-cut, significant, positive effect in diminishing the time to recovery.”
This proves “that a drug can block this virus,” he said, comparing the discovery to the fight for AIDS therapies four decades ago. Fauci said that a smaller Chinese study released separately on Wednesday showing no benefits from remdesivir was “not an adequate study.”
Fauci, the top US scientist for infectious diseases and a key advisor on President Donald Trump’s coronavirus task force, said that US pharmaceutical giant Gilead was in talks with the government to get an early release of remdesivir for the neediest cases.
That would mean seriously ill patients, because the study only examined people already hospitalized, rather than those with mild or early symptoms, he said.
As a veteran of the race to find therapies during the HIV/AIDS crisis starting in the 1980s, Fauci said the results reminded him of early breakthroughs during that era. “It was reminiscent of 34 years ago in 1986 when we were struggling for drugs for HIV and we had nothing,” he said. “It’s opening the door to the fact that we now have the capability of treating” patients.
Fauci stressed that the US study is reliable, unlike the “underpowered” version published in The Lancet after research in Wuhan, China. “It is the first truly high-powered, randomized placebo control trial,” Fauci said.
He said that the Food and Drug Administration would begin by making remdesivir “easily available to those who need it,” but a mass market release would need more complex approval. “The FDA, literally as we speak, is working with Gilead to figure out mechanisms to make this easily available to those who need it,” he said.
The FDA will work “very expeditiously” on wider approval. Trump called the study “a beginning” and “a very positive event.” The study by China-Japan Friendship Hospital and Capital Medical University in China, published earlier in The Lancet, found that remdesivir “did not provide significant benefits over placebo.”
The Wuhan study was conducted in 237 COVID-19 patients, half of whom were given remdesivir. The other half were treated as a control group and given standard antibiotics. The mortality rate was the same in both groups, around 14 percent of each.
“I don’t like to pooh-pooh other studies, but that’s not an adequate study and everybody in the field feels that,” Fauci said.